Efficacy & Safety of Clindamycin and Tretinoin in Acne

Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01111994

Enrollment

Registered

2010-04-28

Start date

2009-11-30

Completion date

2010-04-30

Last updated

2010-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

Keywords

hyperpigmentation

Brief summary

The purpose of this study is ascertain the efficacy and safety of Clindamycin Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post Inflammatory Hyperpigmentation in patients with skin of color.

Detailed description

Acne is a chronic disorder of the pilosebaceous glands characterized by inflammatory papules, pustules, opened and closed comedones, cysts and nodules. Post inflammatory hyperpigmentation is a condition in which an inflammation from a disease such as acne, trauma, or abrasion results in areas of the skin with increased melanin content compared to the surrounding skin. There are several treatments available for acne, which include benzoyl peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin, tazarotene, adapalene). Combination therapy, such as topical retinoid and clindamycin, has been shown to be more effective than monotherapy in addressing all pathogenic factors of acne.

Interventions

DRUGClindamycin Phosphate 1.2% and Tretinoin 0.025% Gel

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation * Photo skin types IV - VI * Ages 12 and older * Both sexes * Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products * Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives

Exclusion criteria

* Seborrheic dermatitis * PIH of solely dermal origin * Acne vulfaris known to be resistant to oral antibiotics * Use of erythromycin-containing products * Use of neuromuscular blocking agents * Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).

Design outcomes

Primary

Measure	Time frame
Improvement of acne and post inflammatory hyperpigmentation	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026